Clinical Trial: A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid Lupus Erythematosus

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase 2, Pilot, Multicenter, Randomized, Placebo-Controlled Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Activity of CC-930 in Subje

Brief Summary: The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated.

Detailed Summary:

Enrollment will occur in sequential, ascending, dose-sequence design, where a higher CC-930 dose level and longer duration of dosing (cohort) will not be initiated until supportive safety profile is demonstrated in the preceding cohort. There will be 4 cohorts as described here;

Cohort 1: 25 mg once daily for 4 weeks Cohort 2: 50 mg once daily for 4 weeks Cohort 3: 100 mg once daily for 6 weeks Cohort 4: 100 mg twice daily for 6 weeks

Sponsor: Celgene Corporation

Current Primary Outcome: Number of subjects with adverse events [ Time Frame: 4 to 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To describe the pharmacokinetics of CC-930 in subjects with recalcitrant DLE. [ Time Frame: 18 months ]

Original Secondary Outcome: Same as current

Information By: Celgene Corporation

Dates:
Date Received: November 4, 2011
Date Started: November 2011
Date Completion:
Last Updated: May 2, 2016
Last Verified: May 2016